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Suppliers and packagers for generic pharmaceutical drug: STIRIPENTOL
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STIRIPENTOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709 | NDA | BIOCODEX, INC. | 68418-7939-6 | 1 BOTTLE in 1 CARTON (68418-7939-6) / 60 CAPSULE in 1 BOTTLE | 2018-08-21 |
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709 | NDA | BIOCODEX, INC. | 68418-7940-6 | 1 BOTTLE in 1 CARTON (68418-7940-6) / 60 CAPSULE in 1 BOTTLE | 2018-08-21 |
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223 | NDA | BIOCODEX, INC. | 68418-7941-6 | 60 PACKET in 1 CARTON (68418-7941-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET | 2018-08-21 |
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223 | NDA | BIOCODEX, INC. | 68418-7942-6 | 60 PACKET in 1 CARTON (68418-7942-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET | 2018-08-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Stiripentol
Introduction
Stiripentol, marketed under brand names such as Diacomit, is an essential anticonvulsant primarily used as an adjunctive therapy for refractory epilepsy associated with Dravet syndrome. Since its initial approval, the complexity of its supply chain has garnered significant attention from pharmaceutical companies, healthcare providers, and regulators. This report provides a comprehensive overview of the key suppliers involved in the manufacturing, distribution, and commercialization of stiripentol, alongside an analysis of the market dynamics influencing these suppliers.
Overview of Stiripentol and Its Market
Stiripentol was first approved by the European Medicines Agency (EMA) in 2007 and subsequently received FDA approval in the United States in 2018 as part of the Diacomit therapy. Its unique mechanism involves enhancing gamma-aminobutyric acid (GABA) neurotransmission, making it a critical option for severe pediatric epilepsies. Presently, the drug's manufacturing process involves complex synthesis routes requiring specialized chemical expertise and quality control standards, compounded by regulatory compliance.
The global stiripentol market is characterized by a limited number of dedicated manufacturers, mainly due to the drug's niche positioning, stringent regulation, and the high complexity of chemical synthesis. The primary suppliers are pharmaceutical companies licensed to produce the drug either via proprietary APIs or through licensed manufacturing agreements.
Manufacturers and Key Suppliers
1. Sanofi (France)
Sanofi, a global health care leader, holds the original patent rights and was the pioneer in manufacturing stiripentol for the European and global markets. The company developed a comprehensive supply chain for the API (Active Pharmaceutical Ingredient) production, including synthesis, quality control, and distribution. Sanofi’s manufacturing facilities are located in France, with a focus on maintaining high GMP (Good Manufacturing Practice) standards.
- API Production: Sanofi's process for synthesis involves complex chemical pathways requiring specialized catalysts and rigorous purification steps, making it a primary supplier for licensed formulations.
- Distribution Network: Sanofi distributes stiripentol through its global supply chain infrastructure, ensuring compliance with international regulatory standards.
2. Nanjing Simcere Pharmaceutical (China)
Nanjing Simcere Pharmaceutical, a reputable Chinese pharmaceutical manufacturer, has been involved in the licensed production of stiripentol API under regional licensing agreements. The company's focus lies in producing high-quality APIs at competitive costs, bolstering supply particularly for Asian markets.
- Supply Capabilities: Capable of producing large API batches corresponding to regional demand, adhering to international Good Manufacturing Practices (GMP).
- Strategic Position: As China continues to expand its role as an API manufacturing hub, Simcere's involvement provides a cost-efficient alternative for global markets outside Europe and North America.
3. Other Contract Manufacturing Organizations (CMOs)
Several CMOs globally are authorized through licensing agreements to manufacture stiripentol API, including:
- Huali Biological Technology (China)
- Jiangsu Hengrui Medicine (China)
These organizations typically operate under Sanofi's licensing or possess approved manufacturing licenses independently.
Note: The limited number of suppliers reflects the complexity of the synthesis process, stringent regulatory controls, and the specialized nature of the drug.
Distribution and Supply Chain Considerations
The distribution of stiripentol is heavily regulated, with key considerations including:
- Regulatory Compliance: Suppliers must adhere to international GMP standards, especially when exporting to markets like the US, EU, Japan, and emerging markets.
- Supply Chain Security: Due to the drug’s critical application in pediatric epilepsy, ensuring an uninterrupted supply chain is paramount; recent supply disruptions have been linked to API shortages from primary producers.
- Pricing and Access: Cost-effective manufacturing in regions like China has influenced global pricing mechanisms, making stiripentol more accessible in low-to-middle-income countries.
Emerging Trends and Future Suppliers
The strategic landscape for stiripentol suppliers is evolving, driven by factors such as:
- Patent Expirations: While Sanofi's patents have secured market exclusivity, patent expirations could lead to increased licensing agreements and new suppliers.
- Generic Development: Existing generic manufacturers are increasingly seeking approval, potentially entering supply chains with alternative API sources.
- Biotech Innovations: Advances in synthetic chemistry and biotechnological methods might introduce new manufacturing platforms, reducing reliance on traditional chemical synthesis.
Regulatory and Quality Standards
Suppliers must meet rigorous standards, including:
- FDA and EMA Approvals for manufacturing facilities.
- GMP Compliance to ensure API purity and consistency.
- Regular audits and validation to prevent supply disruptions and safety issues.
Partnering with established, compliant suppliers mitigates risks related to contamination, quality lapses, and regulatory sanctions.
Conclusion and Strategic Outlook
The supply chain for stiripentol remains concentrated among a handful of high-capacity, compliant manufacturers. Sanofi continues to be the leading global supplier, with significant contributions from Chinese contract manufacturers. An anticipated increase in generic and biosimilar entrants may diversify the supplier base over the next five years, reducing costs and improving access.
Key considerations for stakeholders include ensuring supply chain security, monitoring patent and licensing landscapes, and fostering partnerships with reliable suppliers possessing robust regulatory compliance frameworks.
Key Takeaways
- Limited Supply Base: The stiripentol market is dominated by Sanofi and select Chinese contract manufacturers, reflecting tight control over API synthesis and quality.
- Regulatory Stringency: Suppliers must meet high GMP standards; compliance ensures uninterrupted supply and product safety.
- Market Dynamics: Patent expirations and licensing agreements are opening opportunities for new suppliers, which could diversify sourcing and reduce costs.
- Supply Chain Risks: Disruptions often stem from API shortages at primary manufacturing hubs; strategic planning is essential.
- Future Trends: Innovations in synthesis and manufacturing could introduce alternative suppliers and lower-cost options, expanding access in emerging markets.
FAQs
1. Who are the primary suppliers of stiripentol active pharmaceutical ingredients globally?
Sanofi remains the main licensed producer of stiripentol API, complemented by Chinese contract manufacturers such as Nanjing Simcere Pharmaceutical, Huali Biological Technology, and Jiangsu Hengrui Medicine.
2. How does patent expiry influence the stiripentol supply chain?
Patent expirations can lead to increased manufacturing licenses, allowing more generic producers to enter the market, thereby expanding supply options and potentially reducing prices.
3. What are the key quality standards for stiripentol API manufacturers?
Suppliers must comply with Good Manufacturing Practices (GMP), adhere to EMA and FDA regulations, and undergo regular audits to ensure API purity, consistency, and safety.
4. Are there emerging suppliers for stiripentol?
Yes, emerging biosimilar and generic manufacturers in China and other regions are developing licensed APIs, which may diversify the supply landscape in the coming years.
5. What risks threaten the stability of stiripentol supply?
Supply disruptions can occur due to API shortages, regulatory non-compliance, manufacturing delays, or geopolitical factors affecting international trade.
References
[1] European Medicines Agency. "Stiripentol (Diacomit): Summary of Product Characteristics." 2007.
[2] U.S. Food and Drug Administration. "FDA Approval Letter for Stiripentol (Diacomit)." 2018.
[3] GlobalData. "Pharmaceutical API Manufacturing Landscape." 2022.
[4] Sanofi Annual Report 2022. "Manufacturing and Supply Chain Overview."
[5] World Health Organization. "Cas registry and manufacturing standards for anticonvulsants." 2021.
This detailed overview aims to aid pharmaceutical industry professionals, investors, and regulators in understanding the current stiripentol supplier landscape, informing procurement strategies and market assessments.
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